Ireland
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Recruiting Phase 1

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

NCT06597721 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-11-25
Last updated
2026-09-09

Condition(s) studied

Advanced Solid TumorPDACHNSCC

Investigational drug(s) / intervention(s)

ADCE-T02

ADCE-T02: Administered intravenously

Study summary

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors.

The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.

The expansion phase is now open for enrollment in indications including HNSCC and PDAC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Patients must have pathologically confirmed unresectable advanced solid tumor 2. Patients who have undergone at least one systemic therapy and have progressive disease 3. Patients must have at least one measurable lesion as per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Life expectancy ≥ 3 months. 6. Patients must have adequate organ function as indicated by laboratory values 7. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T02. 8. Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T02. Key Exclusion Criteria: 1. Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload 2. Central nervous system (CNS) metastasis. 3. Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants. 4. Persistent toxicities from previous systemic anti-neoplastic treatments 5. Known past or current coagulation defects leading to an increased risk of bleeding 6. Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias 7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis 8. Prior second malignancy except for: * Well treated basal cell carcinoma or squamous cell carcinoma of the skin. * Low-risk prostate cancer with a Gleason score \< 7 and a PSA level \< 10 ng/mL * Any cancer or in situ cancer the patient has been disease-free for ≥ 2 years.

Primary outcome measure(s)

  • Maximum Tolerated Dose (MTD) of ADCE-T02 — Up to 24 months
    The MTD will be determined using DLTs
  • Recommended Expansion Phase Dose (RED) of ADCE-T02 — Up to 24 months
    The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
  • Type, incidence and severity of Adverse Events — Up to 24 months
    Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0

Trial sites (14)

FacilityCityRegionStatus
Highlands Oncology Group Rogers Arkansas Recruiting
Yale University Cancer Center New Haven Connecticut Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Washington University St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
START San Antonio San Antonio Texas Recruiting
Macquarie University Hospital Macquarie Park New South Wales Recruiting
Scientia Clinical Research Randwick New South Wales Recruiting
Southern Oncology Clinical Research Unit Bedford Park South Australia Recruiting
Peninsula and South Eastern Haematology and Oncology Group (PSEHOG) Frankston Victoria Recruiting
Cabrini Hospital Malvern Victoria Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06597721 on ClinicalTrials.gov ↗ ← All trials in the USA